Achievements & Activities 2014 Work Plan 2015 GTDP Committee 12 November 2014 Frank Milek Aug. Hedinger Chair - GTDP Committee Catherine Martin Univar Vice Chair

GTDP Committee Achievements & Activities 2014 Pharmaceutical ingredients  The Committee closely monitored all activities pertaining to the Directive on falsified medicinal products (FMD). The committee circulated updates, communications and various published reports to the members. Revision of the guidelines on GMP for Medicinal Products: Part 1 Chapter 5: Production. The final version released in 2014 included several of the committee’s suggestions and comments. Monitored activity pertaining to (a) Guidelines - risk evaluation - GMP for pharmaceutical excipients and (b) Guidelines - GDP for Active substances for medicinal products for human use.  Regulatory and Quality Standards Symposium -26 March, 2014 Speakers from the European Commission, European associations Law firms, as well as company executives.

EXCiPACT TM Certification scheme & asbl. EXCiPACT - GMP/GDP auditing & certification of pharma suppliers to reduce customer audits  Fecc via the GTDP Committee supports EXCiPACT TM EXCiPACT has become a free-standing, not-for-profit association (asbl) under Belgian law. The Articles of the Association were signed on 29 January 2014 in Cannes. EXCiPACT certificates have been issued in Canada, France, Germany, The Netherlands, and Saudi Arabia. Fecc hosts and coordinates EXCiPACT training programmes.  Status Certificates – 14+ issued. 4 Auditing bodies have signed an agreement with EXCiPACT – SGS, DQS, mdc (blue inspection) & AJA Registrars. Auditor training programmes Next training programme – November 2014.

 Food, Feed, Cosmetic ingredients Monitoring all relevant legislation and related activities pertaining to Food, Feed and Cosmetic products. The committee regularly invited members and external experts to make presentations on regulatory updates  Other initiatives Contributed to an AT Kearney study on pharmaceutical chemicals distribution

GTDP Committee Work Plan 2015 (1) Pharmaceutical ingredients Systematic monitoring of all developments pertaining to pharmaceutical ingredients and excipients as well as those related to the implementation of the Directive on falsified medicinal products. Monitor the status of GDP Guidelines for APIs & Risk evaluation Guidelines for GMP in Excipients. EXCiPACT TM Certification scheme Actively participate and contribute to the scheme and related implementation. Assist and continue supporting EXCiPACT training programmes. Continue cooperation with IPEC Europe/Americas, EFCG and other stakeholders.

Work Plan 2015 (2) Food, feed and cosmetic ingredients Review and follow all regulatory and legislative developments pertaining to food, feed and cosmetic ingredients. Monitor the Biocidal Product Regulation for issues of relevance Development of tools and training Organise a training course or symposium for members on a hot topic. GTDP Committee

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